A conclusive study of Bayer AG’s aprotinin injection Trasylol uncovered a grim fact: one out of every 50 Trasylol recipients dies. The study was conducted in Canada and involved monitoring the health of 2,331 high-risk heart patients.
Known as BART, the study randomly administered one of three drugs to the patients: Trasylol, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid).
BART sought to answer questions about Trasylol’s safety and efficacy, despite the fact that the drug has been in use for over twenty years. Was Trasylol more effective than alternative drugs in controlling bleeding during cardiac surgery? And, how did rates of death, organ failure, and other serious complications measure in Trasylol compared to the alternative drugs?
Experts conducting the study found that Trasylol’s safety risks were so high, they ended the trial before its scheduled completion. Death rates among Trasylol patients were alarmingly higher than in patients who were given the alternative therapies. Dr. Paul C. Herbert, a critical care physician at Ottawa Hospital and one of the lead investigators, told BusinessWeek magazine that Trasylol represented a 53% increase in risk in dying compared to the other drugs. That “translates into for every 50 patients treated with aprotinin, one patient would die,” he explained.
Strangely, earlier Trasylol tests were small and not designed to study death. Information about the drug’s toxicity in some patients, therefore, remained hidden.
Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine, reacted to the results of BART with the same frustration as many North American consumers. In remarks made to BusinessWeek magazine, he wondered “why it takes so long for the truth to come out.”
“How many patients were lost because of this misadventure in therapeutics?” he asked.